BfArM - Federal Institute for Drugs and Medical Devices

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Oxbryta (voxelotor): Review of the benefit-risk ratio Date: 12. December 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

With the publication of the European Commission's decision on 9 December 2025, the risk assessment procedure for Oxbryta (voxelotor) was completed. 

Study submission and user account Date: 12. December 2025 Type: Article

Study Submission and User Account

Structure of the BfArM in text form PDF, 172KB, File is accessible Date: 08. December 2025 Topics: About BfArM Type: Download

Structure of the BfArM (date 08.12.2025)

Structure of the BfArM PDF, 168KB, File does not meet accessibility standards Date: 08. December 2025 Topics: About BfArM Type: Download

Structure of the BfArM (date 08.12.2025)

Proposal procedure to maintain OPS and ICD-10-GM Date: 03. December 2025 Topics: Kodiersysteme Type: Article

Proposal procedure for ICD-10-GM and OPS

When will devices have to be registered in EUDAMED / when will the use of EUDAMED become mandatory? Date: 01. December 2025 Topics: Medical devices Type: FAQ

Products must continue to be registered in DMIDS until EUDAMED becomes mandatory on 28 May 2026. This will be followed by a six-month transition period, after which all MDR and IVDR products and legacy devices (still on the market on the date of …

Analyse/Research Date: 01. December 2025 Topics: Kodiersysteme Type: Article

Analyse/Research

Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB) PDF, 267KB, File is accessible Date: 01. December 2025 Topics: Kodiersysteme Type: Download

Downloads Iris Institute - Terms and conditions for downloading

Alpha-ID-SE Date: 27. November 2025 Topics: Kodiersysteme Type: Article

The Alpha-ID is a sequential and stable identification number, which is allocated to each entry in the alphabetical index. It permits the encoding of medical and natural language diagnostic terms. Published in 2005 by DIMDI as a prototype, the file …